Comparing 14 F Pigtail Catheter to Traditional 28-32F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax
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|ClinicalTrials.gov Identifier: NCT02553434|
Recruitment Status : Unknown
Verified September 2015 by Narong Kulvatunyou, University of Arizona.
Recruitment status was: Not yet recruiting
First Posted : September 17, 2015
Last Update Posted : September 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Hemothorax||Device: Pigtail catheter||Phase 3|
The standard treatment for traumatic hemothorax (HTX) and hemopneumothorax (HPTX) has been an insertion of a large-bore chest tube (CT) (French 28-32). The procedure is associated with significant patient's pain and discomfort. Investigator's institution has taken a lead role to replace chest tube insertion with pigtail catheter (PC) (14F) insertion. The investigators have previously published that, not only PC works just as well as the traditional CT for both pneumothorax 1) and hemothorax( 2), but it is also associated with a significant less insertion pain and tube site pain (3). In that hemothorax study, investigator reported 36 patients who received PC for HTX (2) with the same success as 32-36F chest tube in term of initial output and success rate; success rate was defined as no further intervention was needed. Since the completion of that study (December 2011), investigator's division has inserted probably 100 PC for hemothorax and hemopneumohthorax Therefore, the investigators now believe that it is time for the investigator to demonstrate the efficacy of the PC for hemothorax with a prospective and randomized study as the investigator had done previously for traumatic pneumothorax (3).
The investigators hypothesize that pigtail catheter will be just as effective as the chest tube in patients with traumatic HTX and HPTX.
The investigators' study aim is to demonstrate the efficacy of the pigtail catheter in a prospective and randomized fashion as we have done previously in pneumothorax.
The investigators' primary end point is the success/failure rate. Failure is defined as a second intervention is required i.e., second tube, video-assisted thoracoscopy (VATS), etc.
The investigators' secondary end points are the amount of initial tube drainage, 24-hour, 48-hour, 72-hour; and complications, hospital length of stay, and chest tube or pigtail insertion experience as expressed by the patient.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospective and Randomized Study Comparing 14 F Pigtail Catheter to Traditional 32-36F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Pigtail catheter (case)
Inserting 14 French pigtail catheter
Device: Pigtail catheter
Insertion of pigtail catheter
Other Name: small-bore catheter
No Intervention: Chest tube
inserting 32-36 French chest tube
- Number of participants with failure of initial intervention [ Time Frame: 1 year ]Requiring a second intervention i.e., second tube, VATS, etc
- initial drainage (blood) output at the time of tube insertion [ Time Frame: 1 year ]the amount of blood that comes out when tube is placed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553434
|Contact: Narong Kulvatunyou, MDemail@example.com|
|Principal Investigator:||Narong Kulvatunyou, MD||University of Arizona|